Comparison of Pilates &Home Exercise Programs on Muscle Strength in Paraplegic Patients

April 22, 2020 updated by: Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Comparison of the Effects of Reformer Pilates and Home Exercise Programs on Upper Extremity Muscle Strength in Paraplegic Patients: Prospective Randomized Controlled Study

Paraplegic patients to be included in the study were divided into 2 groups by randomization and it was planned to apply reformer pilates or home exercise programs for 8 weeks. It was aimed to compare upper extremity muscle strengths, Spinal Cord Independence Measure version III (SCIM-III) and the Short Form(36) Health Survey (SF-36) data before and after treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Spinal cord injuries (SCI) are injuries that occur as a result of compression, incision or contusion of the spinal cord, which extends from foramen magnum to cauda equina.These patients experience various complications and organ system damage in the chronic period.Their self-dependence is affected by the level of injury. One of the most important factors affecting the self-dependence of people with SCI is the strength of the upper extremity.Strong upper extremities are needed for independent transfer from bed.

SCI patients member of Turkish Spinal Cord Injury Association, according to the criteria for inclusion in the study patient list was created. In accordance with the sample size with the random numbers prepared with a computer program from this list, 18 people were planned to be included in the study. The patients were planned to be randomly divided into the study and control groups.Reformer pilates was planned, suitable for the disabled, with an instructor for the patients in the study group for 8 weeks; A home exercise program with telephone monitoring was planned for the patients in the control group for 8 weeks.It was planned to record the demographic data of the patients (age, gender, occupation, additional disease).It was planned to fill the SF-36 form to measure the quality of life of the patients, SCIM-III forms to evaluate functionally and measure the upper extremity muscle strength with a hand dynamometer.

At the end of 8 weeks, the patients were called for an examination, and SF-36, SCIM-III forms were filled and muscle strength was measured, and the comparison was aimed within the group and between the groups.In our study, our aim is to demonstrate the applicability of the reformer pilates program in SCI patients. In addition, to show the effects of home exercise program and reformer pilates programs on upper extremity muscle strength in SCI patients with multiple comparison tests.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Volunteering for study
  • Lesion level: T2 and below diagnosed with SCI
  • Lesion duration over 2 years
  • Ambulation in wheelchair
  • To ensure randomization, SCI patients must be a member of Turkish Spinal Cord Injury Association and which should not be included in any study group.

Exclusion Criteria:

  • Severe psychiatric disorder
  • General condition disorder (heart failure, lung failure)
  • Intolerably shoulder pain during exercise

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Reformer pilates group
Reformer pilates was planned, suitable for the disabled, with an instructor for the patients in the study group for 8 weeks.
Device: Reformer Pilates
Reformer pilates was planned, suitable for the disabled, with an instructor for the patients in the study group for 8 weeks.
Active Comparator: Home exercise group
A home exercise program with telephone monitoring was planned for the patients in the control group for 8 weeks.
Other: Home Exercise
A home exercise program with telephone monitoring was planned for the patients in the control group for 8 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the upper extremity muscle strength
Time Frame: 8 weeks
measure the upper extremity muscle strength with a hand dynamometer
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the Short Form(36) Health Survey (SF-36)
Time Frame: 8 weeks
The SF-36 is a measure of health status.It consists of eight scaled scores, which are the weighted sums of the questions in their section. The lower the score the more disability.
8 weeks
Spinal Cord Independence Measure version III (SCIM-III)
Time Frame: 8 weeks
SCIM-III is a measurement tool for determining the level of function in spinal cord injury
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Investigators

  • Principal Investigator: Fatma N Kesiktaş, Assoc. Prof, Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2019

Primary Completion (Actual)

May 1, 2019

Study Completion (Actual)

July 1, 2019

Study Registration Dates

First Submitted

April 22, 2020

First Submitted That Met QC Criteria

April 22, 2020

First Posted (Actual)

April 24, 2020

Study Record Updates

Last Update Posted (Actual)

April 24, 2020

Last Update Submitted That Met QC Criteria

April 22, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IstPRMTRH

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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